Job description :
Duties and Responsibilities:
1. Clinical Project Manager CPM represents clinical operations at the hands-off meeting, which officially initiates the study.
2. Takes ownership for achieving the final clinical deliverables within the contractual time period specified within the organization contract with the customer.
3. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
4. Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
5. Serves as the primary clinical operations contact for the Global Project Manager and CRAs.
6. Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
7. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
8. Responsible for delivery and/or co-ordination of project specific training for CRA team as applicable
9. Co-ordinates all start up activities, and ensure that timely EC & Regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review.
10. Reviews and follows up on all questions raised by ethics committees.
11. Prepares and monitors clinical activity timelines and metrics.
12. Leads regular conference call meetings with monitors and other clinical team members.
13. Reviews monitoring visit reports and ensures that they are finalized within contractual timeline.
14. Manages CRF collection and query resolution process within expected timelines.
15. Performs co-monitoring visits where necessary.
16. Provides forecast estimates for clinical activities.
17. Consolidate forecasts from other departments to submit to AD/D
18. Completes invoicing tools for Region (as necessary)
19. Provides input to global team on contract modifications and out of scope activity
20. Responsible for team adherence to regional budget
21. Review and approve Pass through costs for invoicing to client, review and approve all direct fee & Investigator invoicing to client.
22. Reviews and approves Investigator Payments in CASCADE as defined within Contract/SoA
23. Responsible for oversight of the budget and contract negotiation between clinical team and clinical sites as contracted by the Client
24. Contributes to the development of the Master Action Plan (MAP) providing clinical related documents.
25. Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
26. Ensures regular project review, using the organization’s tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.
27. In conjunction with the Global Project Manager prepares, organizes and presents at the Investigator Meetings.
28. Provides regular status updates to GPM for client reports and participates in client meetings, as requested.
29. Communicates regularly with all other related departments to ensure timelines, resources, interactions and quality are maintained.
30. Responsible for the timely archiving of documents and study materials for the clinical department.
31. Participates in bid defence meetings to present the clinical organization and management of the proposed study team.
Skills and knowledge:
- Superior organisational skills.
- Extensive previous monitoring experience.
- Lead CRA experience i.e. International CRA co-ordination / several countries
(Knowledge of various country requirements is an advantage).
- Excellent judgment and decision making skills.
- Effective oral and written communication skills.
- Able to communicate well in English, both orally and in writing, other languages would be advantageous.
- Excellent interpersonal skills and problem solving ability.
- Ability to motivate and integrate teams and teach/mentor team members.
- Proficient knowledge of several medical/therapeutic areas and medical terminology.
- Ability to prioritise workload of team members.
- Expert knowledge of all ICH and FDA guidelines (and corporate SOPs/WPDs - internal candidates).
- Computer skills.
• Minimum of five years of clinical monitoring or other relevant clinical operations experience, including international coordinating role.
• Experience in managing global clinical trials.